2013 AABB Blood Survey Report

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THE AABB BLOOD SURVEY REPORT Final The 2013 AABB Blood Collection, Utilization, and Patient Blood Management Survey Report Report Authors Barbee I. Whitaker, PhD Srijana Rajbhandary, BDS, MPH Andrea Harris, MPH Citation AABB, December 18, 2015 Table of Contents List of Tables. v List of Figures . .vii 1. Executive Summary. 1 US Blood Collection . 1 US Blood Utilization . 2 Patient Blood Management (PBM) . 3 2. Key Findings . .5 3. International Report . 9 Blood Collected and Produced . 9 Blood Transfusion . 10 4. Blood Collected and Produced in AABB Member Facilities: Trends in US Collections . 11 Total WB/RBC Collections. 11 Whole Blood (WB) . 11 Red Blood Cell (RBC) Apheresis. 12 RBC Distributions . 14 Non-RBC Components . 14 Platelets . .14 Plasma. 15 Cryoprecipitate . 17 Granulocytes . 18 Blood Center Inventory . 18 5. Blood Transfused by US-Based AABB Member Hospitals . 21 WB and RBCs Transfused . 21 Pediatric Transfusions . 21 Transfusion Recipients. 22 Non-RBC Components Transfused . 22 Outdated Units . 26 iii THE 2013 AABB BLOOD COLLECTION, UTILIZATION, AND PATIENT BLOOD MANAGEMENT SURVEY REPORT 6. Patient Blood Management (PBM) in AABB Member Facilities . 29 PBM Interventions . 31 Measure of Intervention Success . 34 Informed Consent . 35 Type and Screen before Procedures . 36 Transfusion Thresholds . 36 7. Current Issues in Blood Collection and Donor Screening . 43 Donor Hemovigilance . 45 8. Current Issues in Blood Transfusion . 47 US Collection Trends . 47 Blood Availability . 48 Blood Use. 50 Crossmatch Procedures . 52 Red Cell Age. 52 Platelet Age. 52 Hemovigilance . 52 9. Component Costs . 57 RBCs . 57 Plasma . 57 Apheresis Platelets . 58 Reimbursement . 58 Summary . 61 10. Component Modification . 63 Leukocyte Reduction . 63 AABB Member Transfusion of Irradiated and LR Components. 63 11. Appendix I: Methods . 69 Survey Population. 69 Non-US AABB Member Response. 69 US Military Blood Program Response . 69 AABB US Member Data Analysis . 69 Response Rates and Weights. 69 Imputation of Data Items. 72 Characterization of Respondents. 72 Comparison with Previous Surveys . 73 Data Quality Control . 74 Statistical Analysis. 74 Limitations . 74 12. Appendix II: Glossary of Terms . 75 13. Acknowledgements . 77 iv THE 2013 AABB BLOOD COLLECTION, UTILIZATION, AND PATIENT BLOOD MANAGEMENT SURVEY REPORT List of Tables Table 4-1. Estimated 2013 Collection and Transfusion by AABB US Member Blood Centers and Hospitals for Whole Blood (WB) and Red Blood Cells (RBCs) (expressed in thousands of units) . 13 Table 4-2. Estimated 2013 Collection and Transfusion by AABB US Member Blood Centers and Hospitals for Non-RBC Components (expressed in thousands of units) . 16 Table 5-1. Pediatric Transfusions by US.

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Requirements for Blood and Blood Components Intended for Transfusion Or for Further Manufacturing Use
Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use Office of Blood Research and Review CBER, FDA Ask the FDA Session – AABB Annual Meeting October 26, 2015 1 Outline • Overview – Historical Background – Intent of the Rule – Organization of the Rule • Selected Provisions – Relevant Transfusion-Transmitted Infection – Control of Bacterial Contamination of Platelets – Medical Supervision – Donor Acknowledgement – Alternative Procedures – Donor Eligibility • Implementation 2 GAO Oversight and FDA Concerns • Publish in the form of regulations the guidelines that FDA deems essential to ensure the safety of the blood supply • Concern about the delay in requiring testing for emerging infectious agents, e.g. HTLV • Concern about blood safety and the regulations being out-of-date • Concerns about donor safety 3 Intent of the Final Rule • To better assure the safety of the blood supply and to help protect donor health • To make donor eligibility and testing requirements more consistent with current practices and to provide flexibility with regard to emerging infectious diseases • To accommodate technological advances • To establish requirements for donor education, donor history, and donor testing 4 Organization of the Final Rule - 1 • A. General • B. Definitions (§§ 606.3, 610.39, 630.3, 640.125) • C. Standard Operating Procedures (§ 606.100) • D. Control of Bacterial Contamination of Platelets (§ 606.145) • E. Records (§ 606.160) • F. Test Requirements (§§ 610.40, 640.5, 640.71(a)) • G. Donor Deferral (§ 610.41) 5 Organization of the Final Rule - 2 • H. Purpose and Scope (§ 630.1) • I. Medical Supervision (§ 630.5) • J. General Donor Eligibility Requirements(§ 630.10) • K. Donor Eligibility Requirements Specific to Whole Blood, Red Blood Cells and Plasma Collected by Apheresis (§ 630.15) • L.
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